International Medical Device Regulatory Monitor

The U.S. Food and Drug Administration (FDA) has once again pushed back the release of its long-anticipated proposed unique device identifier (UDI) rule, which had been set to come out this year.

Devicemakers in the UK are lagging behind their drug counterparts in implementing the National Health Service’s (NHS) bar coding initiative, but global efforts to introduce a unique device identifier (UDI) system are expected to provide more impetus. Includes the full text of UK’s DoH Review of Bar Coding Performance.

Devicemakers hoping for an EU-wide patent system can blame the delay on language.

Sponsors of combination products in the EU are advised to have a pre-submission meeting with the relevant notified body at least six months before they expect to submit their application, a proposed guideline from the European Medicines Agency (EMA) says. Includes the full text of EMA’s Draft Procedures for Ancillary Products.

Spain must align its value-added tax (VAT) for medical devices and substances used in pharmaceuticals with the EU VAT Directive or face the possibility of being referred to the EU Court of Justice.

Greece is facing millions of dollars in financial penalties for refusing to accept devices with CE markings.

Devicemakers have to comply with the EU’s Medical Device Directives (MDD) when their “devices are placed on the market,” but the directives failed to define that term — an oversight the European Commission (EC) is correcting.

Small European device companies wanting to expand into China have a new resource, the EU’s Centre for Small and Medium Enterprises (SMEs).

Hoping to improve access to the Japanese market, representatives of the U.S. device industry met with senior Japanese officials to discuss ways to address the country’s complicated regulatory and reimbursement systems.

Before investigating an existing or potential nonconformity, a devicemaker should have a documented plan in place, a final guidance from the Global Harmonization Task Force (GHTF) advises.

Devicemakers are taking a wait-and-see attitude toward Ireland’s new guidelines on weighing the cost of healthcare technologies.

To increase transparency, Australia’s Therapeutic Goods Administration (TGA) is reviewing how it communicates regulatory processes and decisions.

European devicemakers are using a study that’s critical of the U.S. Food and Drug Administration (FDA) to promote how well the EU’s regulatory system is working.

Devicemakers that develop products designed for home use will likely see new labeling requirements as part of an upcoming guidance from the U.S. Food and Drug Administration (FDA).

Companies distributing some devices in Canada can now use electronic labels, as long as they follow labeling requirements in the country’s Medical Devices Regulations.

Giving devicemakers two inspections for the price of one, Health Canada (HC) and the U.S. Food and Drug Administration (FDA) have agreed to move forward with a joint third-party inspection program.